NCT00078247

Brief Summary

This study is designed to determine whether 6 months of anti-HIV drugs given along with tuberculosis treatment will delay the onset of AIDS in HIV infected African patients.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
350

participants targeted

Target at P25-P50 for phase_3 hiv-infections

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 20, 2004

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 23, 2004

Completed
7 months until next milestone

Study Start

First participant enrolled

October 1, 2004

Completed
Last Updated

August 12, 2010

Status Verified

August 1, 2010

First QC Date

February 20, 2004

Last Update Submit

August 10, 2010

Conditions

HIV InfectionsTuberculosis

Keywords

Antiretroviral TherapyAfrica

Outcome Measures

Primary Outcomes (2)

  • CD4+ decline (slope)

    Throughout study

  • Time to AIDS

    Throughout study

Secondary Outcomes (4)

  • Safety

    Throughout study

  • Response to antituberculous therapy

    Throughout study

  • Immune reconstitution

    Throughout study

  • Viral drug resistance

    Throughout study

Study Arms (2)

1

EXPERIMENTAL

Participants will receive 6 months of ARV therapy and treatment for TB

Drug: AbacavirDrug: LamivudineDrug: ZidovudineDrug: Tuberculosis treatment

2

EXPERIMENTAL

Participants will not receive ARV therapy until CD4 counts drop below 250 cells/mm3. All participants will receive treatment for TB.

Drug: AbacavirDrug: LamivudineDrug: ZidovudineDrug: Tuberculosis treatment

Interventions

AbacavirDRUG

300 mg tablet taken orally twice daily

12
LamivudineDRUG

300 mg tablet taken orally daily

12
ZidovudineDRUG

300 mg tablet taken orally twice daily

12
Tuberculosis treatmentDRUG

Tuberculosis treatment

12

Eligibility Criteria

Age13 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Diagnosis of pulmonary TB (AFB smear-positive or culture-positive)
  • HIV infected
  • CD4 count greater than 350 cells/mm3
  • Residence within 20 km of Kampala, Uganda
  • Willing to use acceptable forms of contraception during the study and for 6 weeks after stopping study medication
  • Parent or guardian willing to provide informed consent, if applicable

You may not qualify if:

  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Makerere University Medical School

Kampala, Uganda

Location

Related Publications (1)

  • Chamie G, Charlebois ED, Srikantiah P, Walusimbi-Nanteza M, Mugerwa RD, Mayanja H, Okwera A, Whalen CC, Havlir DV. Mycobacterium tuberculosis microbiologic and clinical treatment outcomes in a randomized trial of immediate versus CD4(+)-initiated antiretroviral therapy in HIV-infected adults with a high CD4(+) cell count. Clin Infect Dis. 2010 Aug 1;51(3):359-62. doi: 10.1086/654799.

    PMID: 20569064DERIVED

MeSH Terms

Conditions

HIV InfectionsTuberculosis

Interventions

abacavirLamivudineZidovudine

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesMycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and Mycoses

Intervention Hierarchy (Ancestors)

ZalcitabineDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesDideoxynucleosidesThymidine

Study Officials

  • Christopher C. Whalen, MD

    Case Western Reserve University

    PRINCIPAL INVESTIGATOR

  • Roy Mugerwa, MD

    Makerere University

    PRINCIPAL INVESTIGATOR

  • Diane Havlir, MD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

February 20, 2004

First Posted

February 23, 2004

Study Start

October 1, 2004

Last Updated

August 12, 2010

Record last verified: 2010-08

Locations

UG(1)